A system and method for facilitating osteotomy of the pelvic

ABSTRACT

A surgical implant system includes a surgical implant and at least one fixation device. The surgical implant includes a first side member, a second side member, a distal member and a proximal member. The first side member is disposed in opposed relation relative to the second side member, the first and second side members including distal and proximal ends. The distal member is disposed in opposed, spaced relation relative to the proximal member. The distal member extends across one end of the surgical implant between the first and second side member connecting distal ends of the first and second side members. The proximal member extends across a second end of the surgical implant connecting the proximal ends of the first and second side members. The fixation device is inserted in and advanced through osseous tissue and traverses the openings of the first and second side members.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S.Provisional Patent Application Ser. No. 62/679434, filed on Jun. 1,2018, the entire content of which is hereby incorporated herein byreference.

TECHNICAL FIELD

The present disclosure relates generally to orthopedic surgical devicesand systems, and more particularly, to surgical implants, surgicalimplant systems, and methods of cutting of, and securing implants toosseous tissue.

BACKGROUND

Skeletal disorders or deformities can cause depressed ability to walk,balance or perform routine daily functions. Spinal disorders withexaggerated curvature of the spine, such as kyphosis or lordosis, areexamples of a skeletal disorder which affect alignment and balance of apatient. Congenital short femur is another skeletal disorder in whichone femur is slightly or significantly shorter/smaller than the otherfemur, causing a limp.

Correction surgeries and other methods directly addressing the spine andthe femur have been used to correct balance and improve general skeletalalignment. In patients with spinal deformities, treatments have focusedon correcting spine parameters. For congenital short femur, liblengthening has been the standard treatment. However, the currenttreatments are complex, inefficient and, expensive and have lengthyrecovery time for the patient. Other devices, systems and methods areneeded to achieve efficient, less complex and more economical correctionof skeletal deformities and disorders.

SUMMARY

In an embodiment, a surgical system A surgical implant assemblycomprises at least one surgical implant comprising, a first side member,including at least one first opening, a first side member distal end anda first side member proximal end; a second side member, including atleast one second opening, a second side member distal end and a secondside member proximal end and disposed in opposed relation relative tothe first side member; and, a distal member including a right end and aleft end, interconnecting the first and second side members, the rightend connecting to the first side member distal end and the left endconnecting to the second side member distal end; and, a fixation device,the fixation device insertable through the at least one first openingand the at least one second opening. The surgical implant assemblyfurther comprises a top member and; a bottom member disposed in opposed,spaced relation relative to the top member, the top and bottom membersare interconnected through their parameter by the first side member, thesecond side member, the distal member and the proximal member. The topmember and/or the bottom member may be planar or non-planar. The atleast first opening may be disposed in opposed relation relative to andaligned with the at least second opening. The surgical implant assemblyfurther comprises a bone plate including an elongate body extendingbetween a first end portion and a second end portion, the elongate bodypositioned adjacent the proximal member of the surgical implant. Thesurgical implant further comprises a first curved proximal portion atthe proximal end of the first side member; and, a second curved proximalportion at the proximal end of the second side member, wherein the firstend portion and the second end portion of the bone plate when positionedadjacent to the surgical implant conform to the shape of the firstcurved proximal portion and the second curved proximal portion. Thesurgical implant may have generally a trapezoidal shape including afirst angle defined between the distal end of the first side member andthe right end of the distal member, and, a second angle defined betweenthe distal end of the second side member and the left end of the distalmember. The surgical implant assembly may further comprise a secondfixation device for stabilizing and compressing osseous tissue, thesecond fixation device traverses a space created upon installing thesurgical implant, wherein the second fixation device does not contactthe surgical implant. The surgical implant may have equal first andsecond angles. The surgical implant may include different first andsecond angles the first and second angles may range from about 90° toabout 135°. The first side member and/or the second side member may beplanar or non-planar. The first side member and/or the second sidemember may have variable widths along their lengths. The at least aportion of the first and second side member may have a textured finish.The surgical implant assembly may comprise multiple surgical implants,wherein the surgical implants are stackable, each of the multiplesurgical implants comprising, at least one connection means forconnecting the surgical implant to an adjacent surgical implant in astack of surgical implants.

A method of implanting a surgical implant into an osseous tissuecomprising, forming an opening in the osseous tissue; inserting asurgical implant into the opening of the osseous tissue, the surgicalimplant comprises a first side member, including at least one firstopening, a first side member distal end and a first side member proximalend; a second side member, including at least one second opening, asecond side member distal end and a second side member proximal end, thesecond side member disposed in opposed relation relative to the firstside member; and, a distal member including a right end and a left end,interconnecting the first side member and the second side member, theright end connecting to the first side member distal end and the leftend connecting to the second side member distal end; and, inserting atleast one fixation device through the at least one first opening and theat least one second opening to anchor the surgical implant to theosseous tissue. The method may further comprise attaching at least onebone plate to the proximal member of the surgical implant, the boneplate comprising an elongate body extending between a first end portionand a second end portion. The method may further comprise insertingfixation devices through the first and second end portions of the boneplate to anchor the bone plate to the osseous tissue. The method whereinthe surgical implant further comprises at least one cavity defined inthe surgical implant and filling the at least one cavity of the surgicalimplant with bone growth material.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

FIG. 1A is a 3-dimensional view of an embodiment surgical implant.

FIG. 1B is a 3-dimensional view of an embodiment surgical implant.

FIG. 1C is a 3-dimensional view of an embodiment surgical implant.

FIG. 1D is a 3-dimensional view of an embodiment surgical implant.

FIG. 1E is a 3-dimensional view of an embodiment surgical implant.

FIG. 2A is a side view of first and second side members of an embodimentsurgical implant.

FIG. 2B is an end view of the first and second side members of anembodiment surgical implant.

FIG. 2C is a side view of the first and second side members of anembodiment surgical implant.

FIG. 2D is a side view of exemplary first or second side member of anembodiment surgical implant.

FIG. 2E is a 3-dimensional view of a portion of an embodiment surgicalimplant.

FIG. 2F is a 3-dimensional view of a portion of an embodiment surgicalimplant.

FIG. 3A is a top view of an embodiment surgical implant.

FIG. 3B is a top view of an embodiment surgical implant.

FIG. 4 is top and side views of an embodiment surgical implant.

FIG. 5A is a top view of an embodiment surgical implant.

FIG. 5B is a top view of a surgical implant system or assembly and aside view of an embodiment bone plate.

FIG. 6A is a 3-dimensional view of an embodiment surgical implant.

FIG. 6B is a 3-dimensional view of an embodiment surgical implant andpelvic bone.

FIG. 6C is a side view of an embodiment surgical implant.

FIG. 7A is side view of an embodiment surgical implant.

FIGS. 7B-7C are top views of embodiment surgical implants.

FIG. 8A is a side view of an embodiment stackable surgical implantsystem.

FIG. 8B is a 3-dimensional view of an embodiment stackable surgicalimplant system.

FIGS. 9A-9C are 3-dimensional views of components of an embodimentstackable surgical implant system.

FIG. 10 is a side view of an embodiment surgical implant guiding system.

FIG. 11A is a top view of an embodiment fixation device guide.

FIG. 11B is a 3-dimensional view of a portion of an embodiment fixationdevice guide.

FIG. 11C is a 3-dimensional view of a portion of an embodiment fixationdevice guide.

FIGS. 11D-11E are 3-dimensional views of portions of an embodimentfixation device guide.

FIG. 11F is a 3-dimentional view of an embodiment fixation device guide.

FIG. 12 is a side view of a pelvic bone, illustrating the surgicalimplant of FIG. 1A positioned in the pelvic bone and furtherillustrating the surgical implant guiding system of FIG. 10 .

FIG. 13A is a 3-dimensional view of an embodiment osteotome guidesystem.

FIG. 13B is side views of an embodiment osteotomy protector.

FIGS. 14A-14C is 3-dimentsional views of embodiment osteotome guides.

FIG. 15A is a side view of an embodiment osteotome guide system.

FIG. 15B is a 3-dimensional view of an embodiment osteotome guidesystem.

FIG. 15C is a 3-dimensional view of an embodiment osteotome guidesystem.

FIG. 16A is side views of embodiment cutting devices or osteotomes.

FIG. 16B is a 3-dimensional view of an osteotome of FIG. 16A engagedwith the osteotome guide system of FIG. 13A.

FIG. 17 is a side view of a pelvic bone of FIG. 12 , and the osteotomeguide system of FIG. 15A.

DETAILED DESCRIPTION

While the principles of the present disclosure are described below withrespect to osteotomy of and implant into the pelvic bone, it should beunderstood that the surgical system and implant of the presentdisclosure are suitable for insertion into any osseous tissue and/or usein a variety of surgical procedures. Accordingly, a person of ordinaryskill in the art will readily appreciate that the size and/or shape ofthe surgical devices and implants, or components thereof, can bemodified for proper alignment and fit within a desired osseous tissue.

In an embodiment, FIG. 1A illustrates a 3-dimensional view of a surgicalimplant 100 comprising a first side member 101, a second side member102, a distal member 103, a proximal member 104. The first side member101 and the second side member 102 are disposed in opposed relationrelative to each other. The distal member 103 and proximal member 104are disposed in opposed, spaced relation relative to each other andinterconnect the first and second side members 101, 102. Each of thefirst and second side members 101, 102 includes a proximal end 101 a,102 a and a distal end 101 b,102 b, respectively. The distal member 103and proximal member 104, each include a right end 103 a, 104 a and aleft end 103 b, 104 b, respectively. The distal member 103 interconnectsthe first and second side members 101, 102 by connecting each of thefirst and second side member distal ends 101 b, 102 b at the right andleft ends 103 a, 103 b of the distal member 103, respectively. Theproximal member 104 interconnects the first and second side members 101,102 by connecting each of the first and second side member proximal ends101 a, 102 a at the proximal member right and left ends 104 a, 104 b,respectively. At least a cavity 109 exists within the boundaries createdby the interconnection of first side member 101, second side members102, and the distal member 103 and proximal member 104.

In an embodiment, the distal member 103 may have different shapes,including rectangular, triangular, oblong, circular, square ortrapezoidal. In an embodiment as shown in FIG. IA, the distal member 103may be rectangular in shape with a length “L₁₀₃” that is longer than itswidth “W₁₀₃,” the distal member extends across the surgical implant 100connecting the distal ends of the first and second side members 101,102. The distal member 103 further includes a right end 103 a, a leftend 103 b, a top end 103 c and a bottom end 103 d. In yet anotherembodiment defined therein, the distal member 103 comprises external andinternal surfaces 1031, 1032, respectively.

In an embodiment, the proximal member 104 may have different shapes,including rectangular, triangular, oblong, circular, square ortrapezoidal. In an embodiment as shown in FIG. 1A, the proximal member104 may be rectangular in shape with a length “L₁₀₃” that is longer thanits width “W₁₀₃,” the proximal member extends across the surgicalimplant 100 connecting the proximal ends of the first and second sidemembers 101, 102. The proximal member 104 may further include a rightend 104 a, a left end 104 b, a top end 104 c and a bottom end 104 d. Inyet another embodiment defined therein, the proximal member 104comprises external and internal surfaces 1041, 1042, respectively.

In an embodiment, the distal and proximal members 103, 104 may bedisposed in parallel or non-parallel relations relative to each other.For example, as illustrated in FIG. 1A, the distal member 103 isdisposed in opposed, parallel, spaced relation relative to the proximalmember 104, such as in a surgical implant 100 having isoscelestrapezoidal shape. In yet another embodiment, the distal member 103, maybe disposed in a non-parallel relation relative to the proximal member104 to accommodate anatomical variability in patients.

In an embodiment as illustrated in FIG. 1A, the surgical implant 100 mayhave different shapes and dimensions. Example of different shapesinclude trapezoidal (including irregular quadrilateral/trapezium,trapezoid and isosceles trapezoid), triangular, square, or rectangular.FIG. 1A illustrates a trapezoidal surgical implant 100 wherein thedistal member 103 and proximal member 104 are disposed in opposed,spaced relation relative to each another and the length “L₁₀₃” of thedistal member 103 is shorter than the length “L₁₀₄” of the proximalmember 104. The width “W₁₀₃” of the distal member 103 may be the same ordifferent relative to the width “W₁₀₄” of the proximal member 104. In anembodiment, the widths “W₁₀₃” and “W₁₀₄” may be determined in relationto the widths “W1” and “W2” of the first and second side members,respectively. As illustrated in FIG. 1A, the width “W₁₀₃” of the distalmember 103 is equal to the width “W₁₀₄” of the proximal member 104,because the first and second side members 101, 102 are substantiallyrectangular in shape with equal width “W1” and “W2.” In otherembodiments described therein, the first and second side member 101, 102may take the anatomical shape and dimensions of the bone cross-sectionadjacent to which the first and second side members 101, 102 arepositioned, in which case each of the first and second members 101, 102may demonstrate variable widths along its length.

In an embodiment, each of the first and second side member 101, 102 maycomprise a distal end 101 b, 102 b and a proximal end 101 a, 102 a. Thefirst and second side member distal ends 101 b, 102 b may connect to theright and left ends 103 a, 103 b of the distal member 103 forminginternal angles A°₁₀₁ and A°₁₀₂, respectively. The angles A°₁₀₁ andA°₁₀₂ may be equal to or different from one another, depending on theanatomical change or correction desired for a patient.

In an embodiment, the angles A°₁₀₁ and A°₁₀₂ may be equal to or greaterthan about 90°. As illustrated in FIG. 1A, A°₁₀₁ and A°₁₀₂ are equal toone another and greater than about 90° to form a trapezoid surgicalimplant 100. In an embodiment, the A°₁₀₁ and A°₁₀₂ may range from about90° to about 140°. Any angular degree may be selected for the A°₁₀₁ andA°₁₀₂ to adjust or correct anatomical or skeletal alignments, such as byadjusting pelvic incidence, or correct or improve any balance issues.For example, the A°₁₀₁ and A°₁₀₂ may each independently be about 90°,92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°,116°, 118°, 120°, 122°, 124°, 126°, 128°, 130°, 132°, 134°, 136°, 138°,140°. In embodiments, the A°₁₀₁ and A°₁₀₂ are from about 90° to about135°. In other embodiments, the A°₁₀₁ and A°₁₀₂ are from about 100° toabout 125°.

In an embodiment, each first and second side member 101, 102 may includeat least one opening, 107, 108, respectively. The at least one opening107, 108 may have different shapes. For example, as illustrated in FIG.1A, the at least one opening 107, 108 may be rectangular and extendsubstantially the entire length of the first and second side members101, 102, respectively. In another embodiment, the at least one opening107, 108 may partially extend the length of the first and second sidemember 101, 102, respectively. In yet another embodiment, the at leastone opening 107, 108 may include different shapes, such as, round,oblong, trapezoidal, rectangular or square.

In an embodiment, FIG. 1B illustrates a 3-dimensional view of a surgicalimplant 100 comprising a first side member 101, a second side member102, a distal member 103, a proximal member 104, a top member 105, and abottom member 106. The distal ends 101 b and 102 b of the first andsecond side members 101, 102 may come together to define the distalmember 103. The top member 105 and the bottom member 106 are disposed inopposed, spaced relation relative to each other, and are interconnectedaround their perimeter by the first side member 101, the second sidemember 102, the distal member 103, and the proximal member 104. Togetherfirst side member 101, the second side member 102, the distal member103, the proximal member 104 the top member 105, and the bottom member106 define a cavity 109 within the surgical implant 100.

The at least one cavity 109 of the surgical implant 100 can reduce thedensity and/or the stiffness of the surgical implant 100. The at leastone cavity 109 may be any shape including, for example, round, oblong,or square, and/or may be defined by concave surfaces. The at least onecavity 109 can extend through one or more surfaces (e.g., the first andsecond side members 101, 102) of the surgical implant 100. It should beunderstood that a surgical implant 100 may include at least one cavity109 of any suitable size and geometry.

The at least one cavity 109 can be configured and dimensioned to receivea bone growth material therein. As used herein, a “bone growth material”can be any material that facilitates osteogenesis. Suitable bone growthmaterials can be resorbable or non-resorbable, osteoconductive orosteo-inductive, and combinations thereof. Non-limiting examples ofsuitable bone growth materials include synthetic materials, bonemorphogenic proteins, and heterologous, homologous, or autologous boneand derivatives thereof.

In an embodiment, as illustrated in FIG. 1B, the surgical implant may besubstantially triangular in shape with a first angle “A°₁” formedbetween the distal end of the first side member 101 b and the distal endof the second side member 102 b. The first angle “A°₁” may range fromabout 3° to about 50°. In other embodiments, the first angle “A°₁” maybe about 5° to about 45°. The surgical implant 100 may have any firstangle “A°₁” to adjust or correct anatomical or skeletal alignments, suchas by adjusting pelvic incidence, or correct or improve any balanceissues.

FIG. 1C illustrates a 3-dimensional view of the surgical implant 100including more than one circular opening 1071, 1072, 1073, 1074, 1075,1076, 1078, 1079 on the first side member 101 and more than on circularopenings 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089 on thesecond side member 102. Each circular opening may be configured toreceive a fixation device 110, which may traverse on an “X” axis throughosseous tissue adjacent to the first side member, through a circularopening 1078 on the first side member 101, continue to go through thecavity 109, traverse a circular opening 1088 on the second side member102 and through osseous tissue adjacent to the second side member 102.

A fixation device 110 may be a pin, tap, drill, wire, bone screw and maybe used to secure the surgical implant 100 to osseous tissue. Each ofthe fixation devices 110 may include a head 110 a and a threaded shank110 b extending from the head 110 a. The fixation devices 110 may beself-tapping or self-starting screws.

In an embodiment, the circular openings on the first and second sidemembers 101, 102 may be disposed in opposed, spaced relation relative toeach other and aligned along an “X” axis that runs parallel to thedistal or/and proximal members 103, 104. For example, the fixationdevice 110 may be inserted through the circular openings 1078 and 1088,along the “X” axis. In yet another embodiment, the circular openings onthe first and second side members 101, 102 may be disposed in opposed,spaced relation relative to each other along a “Z” axis which isnon-parallel to the distal or proximal members 103, 104. For example,the fixation device 110 may be inserted through the circular opening1076 and 1082, along the “Z” axis. Because the fixation device 110 maytraverse osseous tissue before it contacts the openings on the first andsecond side members 101, 102, the different axes “X,” “Z” and relatedopenings may ensure that different angles traveled by the fixationdevice 110 are captured as the fixation device 110 contacts an openingon the first and second side members 101, 102.

FIG. 1D illustrates a 3-dimensional view of the surgical implant 100including different types of openings on each first and second sidemembers 101, 102. For example, the first side member opening 107 may berectangular in shape and substantially extend the entire length/width ofthe first side member 101. The second side member 102 may include morethan one second side member openings 1081, 1082, 1083, 1084, 1085, 1086,1087, 1088, 1089. The first side member opening 107 on the first sidemember 101 may be aligned with the more than one second side memberopenings 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089 on thesecond side member 102 in a manner to allow traverse of the fixationdevice(s) 110 through the first side member openings 107 and one of themore than one second side member openings 1081, 1082, 1083, 1084, 1085,1086, 1087, 1088, 1089. For instance, the fixation device 110 maytraverse through osseous tissue and when it reaches the surgical implant100, it traverses through the first side member opening 107, through thecavity 109, and through one of the more than one second side memberopenings 1086.

FIG. 1E illustrates a 3-dimensional view of the surgical implant 100including a first side member 101, a second side member 102 and a distalmember 103. The first and second side members 101, 102 come together toform distal member 103. The surgical implant 100 may be substantially“V” shaped with an angle A°₂. The angle A°₂ may range from about 2° toabout 50°. The A°₂ may be any angle which would allow correction oradjustment in patient's anatomical or skeletal structure or to rectify apatient's balance, among other things.

It is envisioned that the surgical implant 100 may be solid, open-faced,and/or expandable. The surgical implant 100 may be expanded by an activeor passive mechanism and/or include a height expansion/reductionmechanism to allow for dynamic changes to the height and/or length ofthe surgical implant 100. It is contemplated that the changes in theheight and/or length can alter the foregoing angles, such as “A°₁₀₂” or“A₁”, of the surgical implant 100 to accommodate or correct patientanatomy. The surgical implant 100 can be built in-situ by a user insideof osseous tissue to tailor the surgical implant 100 to conform to theanatomy of an individual patient.

In another embodiment, FIG. 2A illustrates a side surface view of eachof the first and second side members 101, 102, each including a length“L1,” “L2” and width “W1,” “W2,” respectively. The first and second sidemembers 101, 102 may have identical or different lengths “L1,” “L2”and/or widths “W1,” “W2,” respectively. Different lengths “L1,” “L2”and/or widths “W1,” “W2” allows for customization of the surgicalimplant to fit a patient's anatomical structure.

In another embodiment, the first side member 101 may include at least afirst side member opening 107 with a length “L1 a” and width “W1 a” andthe second side member 102 may include at least one second side memberopening 108 with a length “L1 b” and width “W1 b.” The shapes and sizesof the at least one opening 107, 108 may be different. For example, thelengths “L1 a” and “L2 a” of the first and second side members 101, 102may substantially extend the entire or a portion of the first and secondside member length “L1,” “L2,” respectively. For example, the first andsecond side member opening 107, 108 may comprise lengths “L1 a” and “L2a” that extend a range of about 4% to about 95% of the lengths “L1” and“L2,” respectively. The lengths “L1 a” and “L2 a” may be identical ordifferent. In embodiments where the opening lengths “L1 a,” “L2 a”represent the short diameter of an elliptical opening, the lengths of“L1 a,” “L2 a” may be determined based on the diameter length of afixation device 110 traversing the opening 107, 108. For instance, thelengths “L1 a,” “L2 a” (e.g., short diameter of an ellipse) may rangefrom about 0.5% to about 20% larger than the diameter of the fixationdevice 110. The lengths “L1 a,” “L2 a” may be about 1%, 3%, 5%, 7%, 9%,11%, 13%, 15%, 17%, 19% larger than the diameter “D” of the fixationdevice 110.

In an embodiment, the widths “W1 a,” “W2 a” of the first and second sidemember openings 107, 108 may substantially extend the entire widths“W1,” “W2” or a faction of widths “W1,” “W2.” For example, the lengths“W1 a” and “W2 a” may extend a range of about 2% to about 95% of thelengths W1 and W2, respectively. In another embodiment, the widths “W1a,” “W2 a” may be determined in relation to the portion of the fixationdevice 110 which will traverse the openings 107, 108. For example, thewidths “W1 a,” “W2 a” may be designed to snugly or loosely hug thetraversing fixation device 110 on its two sides. The widths “W1 a,” “W2a” may be substantially the same as or larger than the diameter of thefixation device 110 traversing them. For instance, the widths “W1 a,”“W2 a” may range from about 0.5% to about 20% larger than the diameterof the portion of the fixation device 110 which traverses the opening107, 108. The widths “W1 a,” “W2 a” may be about 1%, 3%, 5%, 7%, 9%,11%, 13%, 15%, 17%, 19% larger than the diameter of the traversingfixation device 110. In the instances where the openings 107, 108include circular openings, “W1 a,” “W2 a” of the circular openings arethe diameter of the circular opening 107, 108. In the instances whereopenings 107, 108 are elliptical, “W1 a,” “W2 a” of the ellipticalopening may be the short diameter of the ellipse.

In an embodiment, FIG. 2B illustrates an end view of the first andsecond side members 101, 102. The first and second side members each mayhave a depth “D1,” “D2” and width “W1,” “W2,” respectively. The firstand second side member at least one opening 107, 108 may extend thethickness of or depth “D1,” “D2” of the first and second side members101, 102.

In an embodiment, FIG. 2C illustrates a side surface view of the firstand second side members 107, 108 of a surgical implant 100. For example,the first side member 101 may include multiple openings 1071, 1072,1073, each including a length “L1 a” and width “W1 a.” Each first sidemember opening 1071, 1072, 1073 may have similar or different dimensionsrelative to each other, such as similar or different lengths “L1 a”and/or widths “W1 a.”

Similarly, as illustrated in FIG. 2C, the second side member 102 mayinclude multiple openings 1081, 1082, 1083, each including a length “L2a” and width “W2 a.” Each second side member opening 1081, 1082, 1083may have similar or different dimensions relative to each other, such aslengths “L1 b” and widths “W1 b.” In an embodiment, each first sidemember opening 1071, 1072, 1073 may have similar or different length “L1a” and/or width “W1 a” as compared to each second side member opening1081, 1082, 1083 length L2 a and/or width “W2 a.”

In an embodiment, FIG. 2D illustrates side views of exemplary first (orsecond) side members 101 d, 101 e. For instance, the first side member101 d may be substantially triangular including multiple rectangularopenings 107. The first side member 101 d may be substantiallytrapezoidal including multiple circular openings 107. Second side member102 (not shown) may be identical to or different from the first sidemembers 101 d, 101 e.

In an embodiment, the first and/or second side member openings 107, 108may be configured to allow the fixation device 110 to be inserted in theopenings 107, 108 in a multidirectional manner. For example, FIG. 2Eillustrates a 3-dimensional view of a portion of a surgical implant 100comprising multidirectional first and second side member openings 107,108 (partially illustrated). The first side member 101 comprises atleast an exterior surface 1011, an interior surface 1012 and two sidesurfaces 1013, 1014. The first side member may further include amultidirectional opening 1071. The opening 1071 can traverse thethickness D 1 of the first side member 101 and may include a firstopening 1071 a on the first side member exterior surface 1011 connectedto a second opening 1071 b on the first side member interior surface1012. The first opening 1071 a may be rectangular with a length “L1 a”and “W1 a.” The second opening 1071 b may also be rectangular with “L1b” and “W1 b.” In a multidirectional opening, the length “L1 a” andwidth “W1 a” of the first opening 1071 a may be longer than the length“L1 b” and width “W1 b” of the second opening 1071 b, or vice versa.Alternatively, only the length “L1 a” is longer than the length “L1 b,”or vice versa, and the widths “W1 a” and “W1 b” are similar. Thereduction in size of the first opening 1071 a as compared to the secondopening 1071 b allows angular and multidirectional insertion of fixationdevices 110 into the openings, as the fixation device 110 approaches thefirst opening 1071 a as when existing osseous tissue. Similar or reverseconfigurations are contemplated and are apparent for at least oneopening 108 on the second side member 102.

In an embodiment, FIG. 2F illustrates an embodiment surgical implant 100comprising a rectangular opening 1071 in the first side member 101 andan opening 1081 on the second side member 1021. The rectangular opening1071 extends through the thickness of the first side member 1011 andcomprises a first opening 1071 a located on the exterior surface of thefirst side member 1011, a second opening 1071 b located on the interiorsurface of the first side member 1012, a distal side wall 1071 c, and aproximal side wall 1071 d. The distant and proximal side walls 1071 c,1071 d extend across the depth of the first side member andinterconnecting the top and bottom openings 1071 a, 1071 b,respectively. The first opening 1071 a is connected to the secondopening 1071 b through the thickness of the first side member 101. Eachof the first and second openings 1071 a, 1071 b include identical length“L1 a” as compared to “L1 b” and width “W1 a” as compared to “W1 b,”respectively. The first opening 1071 a is disposed in opposed, spacedrelation relative to the second opening 1071 b, wherein the secondopening 1071 b is positioned off alignment relative to the first opening1071 a in a manner that the distal and proximal side walls 1071 c, 1071d of the opening 1071 are not perpendicular to the exterior or interiorsurfaces 1011, 1012 of the first side member 1011.

In an embodiment, FIG. 3A illustrates a top view of an embodimentsurgical implant 100 and exemplary alignments between openings of thefirst and second side members 101, 102. The surgical implant 100 may beconfigured to align each of the openings 1071, 1072, 1073 on the firstside member 101 with a corresponding opening 1081, 1082, 1083 on thesecond side member 102. The purpose of the alignment is to guide thefixation device 110 (not shown) traversing through the surgical implantand to ensure the fixation device traverse through the intended openingsof the surgical implant 100. For example, the openings 1071 and 1082 maybe aligned to allow the fixation device 110 to traverse through theopening 1071 on the first side member 101, the opening 109, and theopening 1081. To achieve the alignment, the length “L1 a” of theopenings 1071, 1072, 1073 on the first side member 101 may be equal tothe length “L2 a” of the openings 1081, 1082, 1082 on the second sidemember 102, for example. In another embodiment, the lengths “L1 a” maybe different from, for example larger than, the length “L2 a.” In anembodiment, the surgical implant 100 may include at least one channel(shown in gray highlight) traversing through and dividing the cavity 109and connecting the openings 107, 108, configured to guide a fixationdevice 100 from one opening 107 the other opening 108. The channelsconnecting the openings 107, 108 may be cylindrical or cube in shape.

In an embodiment, FIG. 3B illustrates a top view of an embodimentsurgical implant 100 and exemplary alignment between openings 1071,1072, 1081, 1082 of the first and second side members 101, 102,respectively, and orientation of fixation devices 110. The first andsecond side members 101, 102 each include at least two aligned openings1071, 1072, 1081, 1082, respectively. The opening 1071 is aligned withopening 1081 and the opening 1072 is aligned with opening 1082. Uponinsertion of a first fixation device 110, it traverses the first opening1071 and the second opening 1081. Upon insertion of the second fixationdevice 110, it traverses the first opening 1072 and the second opening1082.

In embodiments, the first and second side members 101, 102 may be planaror non-planar. The first and second side members may have a convexshape, and/or each may include an inflexion point defining a firstportion having a convex shape and a second portion having a concaveshape. The first side members 101 may have different planarconfigurations from the second side member 102.

In embodiments, the top and bottom members 105, 106 may be planar ornon-planar. The top and/or bottom members 105, 106 may have a convexshape. The top and/or bottom members 105, 106 may include an inflectionpoint defining a first portion having a convex shape and a secondportion having a concave shape.

In an embodiment, FIG. 4 illustrates a top and side views of a surgicalimplant 100 with textured finish. A textured finish can promote bonegrowth, fusion and adhesion with the surgical implant 100. As shown inthe surgical implant 100 a (top and side views), the first and secondside member exterior surfaces 1011, 1021, which come in contact with theosseous tissue, may include ridges angled perpendicular to each of thefirst and second side members 101, 102 or angled A°₃ in a manner topoint the ridges towards the proximal end of each of the first andsecond members 101, 102 to increase stability of the surgical implant100 a and prevent its slippage out of its position in the osseoustissue. Angle A°₃ may range from about 5° to about 89°.

In another embodiment as shown by the surgical implants 100 b and 100 c,each of the first and second side members 101, 102 may include a surfaceroughness or porous exterior surface 1011, 1021. The pores may extendpartially into the surface of the member in which the pores are formedor may extend entirely through the thickness of first and second sidemembers 101, 102 and be open to the at least one cavity 109 of thesurgical implant 100.

In other embodiments, the top member 105 and bottom member 106 may alsoinclude textured surfaces. The textured surfaces may include a surfaceroughness or porous exterior surfaces. The pores may extend partiallyinto the surface of the member in which the pores are formed or mayextend entirely through the entire thickness of top and bottom members105, 106 and be open to the at least one cavity 109 of the surgicalimplant 100.

The textured finish may extend across at least about 10% of therespective surface on which it is disposed. In embodiments, the texturedfinish extends across at least 75% of the respective surface and, insome embodiments, the textured finish extends across at least about 90%of the respective surface. The textured surface can improve adhesionbetween the surgical implant 100 and osseous tissue and/or facilitatebony integration with a biomaterial (e.g., bone growth material) toachieve bone fixation at the interface between the surgical implant 100and the osseous tissue. The textured finish may be formed by subjectinga smooth surface to a surface roughening treatment, such as etching,sand blasting, etc. The textured finished may be structured and define,for example, a surface including substantially pyramidal protrusionswhere each pyramidal protrusion includes a plurality of protrusions orridges disposed thereon to aid in securing the surgical implant 100 toosseous tissue. In particular, each pyramidal protrusion can includeopposed first and second faces that face, respectively, distally andproximally, and opposed third and fourth faces that face, respectively,medially and laterally. For a detailed description of a surgical devicehaving exemplary surface characteristics suitable for use with thesurgical implant 100, reference can be made to U.S. Pat. No. 8,801,791to Soo et al., the entire content of which is hereby incorporated byreference herein.

Variable dimensions, sizes, shapes and angles described above and whichcan be contemplated with respect to the surgical implant 100, such asthe size and dimensions of openings on the first and second sidemembers, allow for prefabrication and/or custom design of surgicalimplants 100 which can fit variable anatomical structures andvariations. The variations can further facilitate insertion of afixation device 110 through a first osseous tissue segment, the opening107 on the first side member 101, the opening 108 on the second sidemember 102, and a second osseous tissue segment to secure the implant inplace and impart compression pressure on the fracture to enhance boneformation and improve healing time. For a detailed description of asuitable computer implement method or system for designing 3D modelsreference can be made to U.S. Pat. Appl. No. 2014/0067106 to PremMakeig, and U.S. Pat. Appl. No. 2013/0211531 to Steines et al., theentire content of each of which is hereby incorporated by referenceherein.

The surgical implant 100 is formed from biocompatible material(s)including, but not limited to, metals and metal alloys, such asstainless steel, cobalt chrome, titanium, and titanium alloys, DriedFrozen Allograft, titanium cage combination with Dried Frozen Allograft,titanium cage with mesh overlying it, as well as polymers, such aspolyether ether ketone (“PEEK”), or combinations of the aforementionedmaterials. The surgical implant 100 may be made using an additivemanufacturing process, for example, by printing or foaming material(s)having sufficient strength, resiliency, and biocompatibility as neededor desired for a surgical procedure. For a detailed description ofadditive manufacturing processes suitable for forming the surgicalimplant 100, reference can be made to U.S. Pat. Appl. Pub. No.2016/0213485 to Schaufler et al., U.S. Pat. Appl. Pub. No. 2016/0213487to Wilson et al., U.S. Pat. Appl. Pub. No. 2016/0213488 to Moore et al.,and U.S. Pat. No. 9,987,051 to Nunley et al., the entire content of eachof which is hereby incorporated by reference herein.

In an embodiment, FIG. 5A illustrates the surgical implant 100configured to attach to adjacent osseous tissue using fixation devices110. The surgical implant may include at least a first side member 101,a second side member 102 and a distal member 103. The first side members101, at its proximal end 101 a, includes a first curved proximal portion111, and, the second side member 102, at its proximal end 102 a,includes a second curved proximal portion 112. The first curved proximalportion 111 forms an angle A°₄ with the first side member 101 (FIG. 5B).The second curved proximal portion 112 forms an angle A°₅ with thesecond side member 102 (FIG. 5B). The curve of the first curved proximalportion 111 may be the reverse of the curve of the second curvedproximal portion 112 such that the radius of curvature of the firstcurved proximal portion 111 is opposite the radius of curvature of thesecond curved proximal portion 112. The curvature of each of the firstand second curved proximal portion 111, 112 can mimic the curvature ofosseous tissue against which the surgical implant 100 is to be placedsuch that the first and second curved proximal portions 111, 112 conformto the shape of the osseous tissue. In embodiments, one of the first andsecond curved proximal portions 111, 112 may be curved and the otherflat. Using the first and second curved proximal portion 111, 112, thesurgical implant can be secured to the osseous tissue.

In an embodiment system, FIG. 5B illustrate a surgical implant system orassembly 10 including the surgical implant 100 configured to attach to abone plate 500 and a side view of an embodiment bone plate and fixationdevices 110. The surgical implant 100 and the bone plate 500 may be usedto secure the surgical implant 100 to the osseous tissue and to create acavity 109 inside the implant 100.

In embodiments, a bone plate 500 may include an elongate body 501extending between a first end portion 502 and a second end portion 503.The elongate body 501 may be flat (i.e., planar), and the first andsecond end portions 502, 503 may be curved. The curve of the first endportion 502 may be the reverse of the curve of the second end portion503, such that the radius of curvature of the first end portion 502 isopposite the radius of curvature of the second end portion 503. Thecurvature of each of the first and second end portions 502, 503 canmimic the curvature of the surgical implant first and second curvedproximal potions 111, 112 or the osseous tissue against which the boneplate 500 is to be positioned. In embodiments, the bone plate may bepositioned adjacent to the proximal member 104 such that the first andsecond end portions 502, 503 conform to the shape of first and secondcurved proximal potions 111, 112. In embodiments, one of the first orsecond end portions 502, 503 may be curved and the other flat.

In embodiments, the bone plate 500 may be placed adjacent to theproximal member 104 of the surgical implant 100 and the attachment screwmay be inserted through a central opening of the bone plate 500 and intothe surgical implant 100 to secure the bone plate 500 thereto. Theorientation of the bone plate 500 relative to the surgical implant 100may be adjusted prior to tightening the attachment screw to, forexample, ensure that the first and second end portions 502, 503 of thebone plate 500 are contoured to the outer surface of the pelvic bone.For a detailed description of securing a bone plate 500 to a surgicalbone plate using an attachment screw inserted through the center openingof the bone plate 500 and into the surgical implant 100, reference canbe made to U.S. Pat. Appl. Pub. No. 2019/0038329A1 to Poelstra et al.,the entire content of each of which is hereby incorporated by referenceherein.

The first and side members 101, 102 of the surgical implant 100 may beinclude the shape of the bone adjacent to which they will be placed.FIGS. 6A-6C illustrate the shape of the first and second side members101, 102, in embodiments where the surgical implant 100 is used tocorrect or adjust anatomical structure or balance by insertion of thesurgical implant 100 in the pelvis bone 601. As illustrated in FIGS.6A-6B, the first and second side members 101, 102 may have contouredshapes which exactly matches the cross-section of the pelvic bonecontours 602, when the bone is cut at or about the anterior inferioriliac spine (AIIS). Matching of the shape of the first and second sidemembers 101, 102 of the surgical implant 100 allows for improvedstability and congruity between the surgical implant 100 and the pelvicbone. FIG. 6B further illustrates an empty space “S” at the distal endof a trapezoid shaped surgical implant 100. As shown in FIG. 12 , asecond fixation device 110 may be inserted through the ilium, traversingthrough a space “S” and continue through the ischium to prevent thesurgical implant 100 to move distally, stabilize the fracture andpromote efficient healing by applying compression forces.

In an embodiment, FIG. 6C illustrates a side view of the surgicalimplant 100 showing variable widths along the length “L1” of the firstside member 101. Although FIG. 6C illustrates the contours andcomponents of the first side member 101, it is contemplated that thesecond side member 102 can mirror the same contour and may include thesame components as discussed with respect to the first side member 101.For example, the first side member 101 includes a first width “W1”extending across the proximal member 104 at the proximal end 101 a ofthe first side member 101, a second width “W2” extending across a firstsection 101 c of the first side member 101 disposed adjacent to theproximal end 101 a and that includes at least a first channel opening603 configured to guide a fixation device 110 (not shown), a third width“W3” extending across a second section 101 d of the first side member101 disposed adjacent to the distal end 101 b of the first side member101, and a fourth width “W4” extending across the distal member 103 ofthe surgical implant 100 at the distal end 101 b of the first sidemember 101.

The first width “W1” at the proximal end 101 a of the first side member101 may be wider than the fourth width “W4” at the distal end 101 b ofthe first side member 101, and/or the first side member 101 may bewidest at the second width “W2.” For example, as shown in FIG. 6C, thewidth of the first side member 101 may increase from the first width“W1” to the second width “W2,” taper to the third width “W3,” and taperfurther to the fourth width “W4.” It should be understood that the firstand second side members 101, 102 of the surgical implant 100 may haveany suitable width or variable width profile. The first width “W1” ofthe first or second side members 101, 102 of the surgical implant 100may range from about 5 mm to about 50 mm. In embodiments, the firstwidth “W1” ranges from about 20 mm to about 30 mm and, in someembodiments, the first width “W1” is about 25 mm. The second width “W2”of first or second side members 101, 102 of the surgical implant 100 mayrange from about 15 mm to about 45 mm. In embodiments, the second width“ W2 ” ranges from about 20 mm to about 40 mm and, in some embodiments,the second width “ W2” is about 35 mm. The third width “W3” of thesurgical implant 100 may range from about 10 mm to about 40 mm. Inembodiments, the third width “W3” ranges from about 12 mm to about 35 mmand, in some embodiments, the third width “W3” is about 25 mm. Thefourth width “W4” of the first or second side members 101, 102 of thesurgical implant 100 may range from about 2 mm to about 22 mm. Inembodiments, the fourth width “W4” ranges from about 7 mm to about 17 mmand, in some embodiments, the fourth width “W4” is about 12 mm.

As illustrated in FIGS. 7A-7C, the surgical implant 100 may include atleast two channels 603 a, 603 b connecting at least one opening 603 cpositioned on the proximal member 104 to at least a second opening 6031,6032 positioned on each of the first and second side members 101, 102,respectively. The channels 603 a, 603 b are configured to guide fixationdevices 110 diagonally through the surgical implant 100 from theproximal member 104 towards openings 6031, 6032 positioned on each ofthe first and second members 101, 102, to reach and impale adjacentosseous tissue. The use of the channels 603 a, 603 b provide additionalmanners for securing the surgical implant 100 to the osseous tissueusing fixation devices 110.

In an embodiment, FIGS. 8A-8B illustrate stackable surgical implantsystems 800. A stackable surgical implant system 800 may include atleast two surgical implants 100 configured to attach to each othervertically and may be used to gradually increase the angle of anatomicalcorrection on a subject by stacking variable angled surgical implants100 to the stack. FIG. 8A illustrates a stackable surgical implantsystem 800 comprising three surgical implants 100 a, 100 b, 100 c eachhaving equal dimensions and adding identical vertical correction along a“Z” axis.

In an embodiment, FIG. 8B illustrates a stackable surgical implantsystem 800 comprising two surgical implants 100 a, 100 b with variablecontoured first and second side members 101, 102. Each of the surgicalimplants 100 a, 100 b may be connected to each other using connectionmeans 801. Connection means 801 may include magnetic connections,railings, pins or pegs from one implant inserted into bores on anotherimplant, connecting protruding surface of one implant to the recessedsurface of the other, or snap and click mechanisms. The connection means801 may further include connecting surgical implants 100 chemically, orby use of adhesive material. The stacked implants 100 may remain looselyassociated through their complementary protrusions and recesses or beseparated and reconnected with each other, repeatedly. The connectionmeans 801 may further include connecting surgical implants 100 to oneanother using a fixation device 110 traversing through the first andsecond side openings 107, 108 of each of the surgical implants 100. Inan embodiment, the textured external surfaces of adjacent first andsecond members 101, 102 may also inhibit shifting of stacked implantsand may define a connection means 801. For a detailed description ofconnecting stackable surgical implants 100 and various connecting means801, reference can be made to U.S. Pat. Appl. Pub. No. 2006/0015184 toWinterbottom et al., U.S. Pat. No. 6,123,731 to Boyce et al., U.S. Pat.No. 6,478,825 to Winterbottom et al. and U.S. Pat. No. 9,345,589 to JohnStark, the entire content of each of which is hereby incorporated byreference herein.

In an embodiment, FIG. 8B illustrates a stackable surgical implantsystem 800 comprising at least two surgical implants 100 a, 100 b. Eachsurgical implant 100 a, 100 b includes a railing to connect with theother implant in a manner to align the openings 107, 108 of each of thesurgical implants 100, allowing fixation devices 110 to traverse throughthe multiple surgical implants 100 a, 100 b. Each surgical implant 100a, 100 b may define an angle A°₆ between the first and second sidemembers 101, 102. The angle A°₆ for each surgical implant 100 a, 100 bmay be the same or different and its value may depend on the totaldegree of correction required at the anatomical structure.

In an embodiment, FIGS. 9A-9C illustrate components of a stackablesurgical implant 800 comprising three surgical implants 100A, 100B,100C. Each of the surgical implants 100A, 100B, 100C are shownseparately. FIG. 9A illustrates a base surgical implant 100Arepresenting the lowest stackable implant in a series of three implantswhich includes connection means 801 on the first side member 101A, only.Because the base surgical implant 100A is positioned at the bottom ofthe stack, connection means 801 may not be present on the second sidemember 102A which comes into contact with osseous tissue. Accordingly,the base surgical implant 100A only includes connection means 801, suchas railings, on the first side member 101A for connecting orinterlocking to the surgical implant 100B. As the surgical implant 100stacks the first side member 101A is positioned adjacent to the secondside member 102B of the surgical implant 100B, for example. FIG. 9Billustrates the middle positioned stackable surgical implant 100B whichincludes connection means 801 on the first and second side member 101B,102B to attach to top and bottom positioned surgical implants 100A,100C. FIG. 9C illustrates the top positioned stackable surgical implant100C which includes connection means 801 on the second side member 102C,only. Because the surgical implant 100C is positioned at the bottom ofthe stack, connection means 801 may not be present on the first sidemember 101C which comes into contact with osseous tissue. Accordingly,the top surgical implant 100C includes connection means 801, such asrailings, on the second side member 102C for connecting or interlockingto the surgical implant 100B, the second side member 102C is positionedadjacent to the first side member 101B of the surgical implant 100B, forexample.

In an embodiment, FIG. 10 illustrates a side view of a surgical implantguiding system 1000 comprising a surgical implant 100, a surgicalimplant guide 1001, an attachment mechanism 1005, a fixation deviceguide 1006, and at least one fixation device 110. The attachmentmechanism 1005 and fixation device guide 1006 are each attached toopposite ends of the surgical implant guide 1001. The attachmentmechanism 1005 is configured to removably attached to the surgicalimplant 100. The surgical implant guiding system 1000 allows foraccurate insertion, installation and fixation of the surgical implant100 in an anatomical location, such as in the pelvic bone.

The surgical implant guide 1001 may be formed from metals and metalalloys, such as stainless steel, cobalt chrome, titanium, and titaniumalloys, as well as polymers, such as polyether ether ketone (“PEEK”), orcombinations of the aforementioned materials. The surgical implant guide1001 may be made using an additive manufacturing process, for example,by printing or foaming material(s) having sufficient strength, andresiliency as needed or desired for a surgical procedure. For a detaileddescription of additive manufacturing processes suitable for forming thesurgical implant 100, reference can be made to U.S. Pat. Appl. Pub. No.2016/0213485 to Schaufler et al., U.S. Pat. Appl. Pub. No. 2016/0213487to Wilson et al., U.S. Pat. Appl. Pub. No. 2016/0213488 to Moore et al.,and U.S. Pat. No. 9,987,051 to Nunley et al., the entire content of eachof which is hereby incorporated by reference herein.

In embodiments, the surgical implant guide 1001 includes at least afirst end portion 1002, a middle portion 1003 and a second end portion1004, the first end, middle and second end portions 1002, 1003, 1004 mayinterconnect to dispose the first end portion 1002 in opposed, spacedrelation relative to the second end portion 1004. The first end portion1002 includes a proximal end 1002 a and distal end 1002 b. At the distalend 1002 a, the first end portion 1002 interconnects with the attachmentmechanism 1005. At the proximal end 1002 b, the first end portion 1002interconnects with the middle portion 1003 at an angle A°₇. The secondend portion 1004 includes a proximal end 1004 a and a distal end 1004 b.At the proximal end 1004 a, the second end portion 1004 interconnectswith the middle portion 1003 at an angle A°₈. At the distal end 1004 b,the second end portion 1004 interconnects with the fixation device guide1006. The middle portion 1003 includes a top end 1003 a and a bottom end1003 b. At the top end 1003 a, the middle portion 1003 interconnectswith the proximal end 1004 a of the second end portion 1004 at the angleA°₈. At the bottom end 1003 b, the middle portion 1003 interconnectswith the proximal end 1002 b of the first end portion 1002 at the angleA°7. In embodiments, adjustable joints 1009, 1010 are contemplated atlocations where the first and second end portions 1002, 1004interconnect to the middle potion 1003 to allow the user to achievedifferent angles A°₇, A°₈ during surgical procedures. The middle portion1003 may further include an adjustable knob 1012 configured to adjustthe length “L” of the middle portion 1003. The adjustable knob 1012 mayallow the user to adjust the height of the surgical implant guide 1001based upon the anatomical variations of a patient, such as length of thepelvic bone.

In embodiments, the first end portion 1002 interconnects with anattachment mechanism 1005. The attachment mechanism 1005 may removablyconnect to the surgical implant 100 and may facilitate insertion of thesurgical implant 100 into an anatomical position, such as in the pelvicbone, and adjusting the positioning of the surgical implant 100 when inthe anatomical position, aligning the openings 107, 108 of the surgicalimplant 100 with the openings of the fixation device guide 1006. Forexample, the attachment mechanism 1005 may include clamps, screws,railings, pins and bores, removable adhesive, or breakable plastictongue. The attachment mechanism 1005 may removably connect to thesurgical implant 100 only at the second side member 102 (as illustrated)or at the first and second side members 101, 102. In other embodiments,the attachment mechanism 1005 may removably connect to the surgicalimplant 100 at other components of the surgical implant 100, such as tothe distal or proximal members 103, 104. In embodiments, the attachmentmechanism 1005 further comprises a swivel at the point of connection ofthe implant that allows it to rotate in the medial and lateral plane 30°in either direction to facilitate alignment for fixation deviceinsertion.

At its distal end 1004 b, the second end portion 1004 interconnects tothe fixation device guide 1006. In an embodiment, the fixation deviceguide 1006 may interconnect to the second end portion 1004 throughrotatable joint 1013 configured to allow the fixation device guide 1006to rotate around its axis “X” to assist in orienting the fixation deviceguide 1006 openings with the openings 107, 108 of the surgical implant100. The rotatable fixation device guide 1006 may include a knob 1007 atits free end to allow the user in rotating the fixation device guide1006 around axis “X”. In an embodiment, the rotating joint 1013 mayinclude hard clicks to stop the rotation motion at narrow rotationangles and intervals. In another embodiment, the rotation joint 1013 mayprovide rotational resistance requiring high rotational torque to beapplied by the user to rotate the fixation guide device 1006. In anotherembodiment, the rotatable joint 1013 may include lock and release modesto allow rotation of the fixation device guide 1006 in the release modeand disallow rotation when in the lock position. Rotational resistance,hard clicks, lock and release modes and other adjustable mechanism arecontemplated to allow the fixation device guide 1006 to provide stableangles of insertion of fixation devices 110. In other embodiments, thefixation device guide 1006 may fixedly interconnect to the second endportion 1004. For example, the fixation device guide 1006 may bepre-fabricated with fixation guide openings oriented at variable anglesas described therein and/or personalized to a subject's anatomicalstructure.

The first end portion 1002, middle portion 1003 and second end portion1004 interconnect to dispose the surgical implant 100 in opposite,spaced relation relative to the fixation device guide 1006. In thisoppose, spaced relation, the fixation device guide 1006 facilitatesinsertion of fixation devices 110 into the pelvic bone and through theopenings 107, 108 of the surgical implant 100. Angles A°₇, A°₈ areconfigured to guide the fixation devices 110 from the fixation deviceguide 1006 to the surgical implant 100 and may each range from about 5°to about 179°, more particularly from about 45° to about 135°.

FIGS. 11A-11F illustrate alternative embodiments of fixation deviceguide 1006. Fixation device guide 1006 may be used to pass and guidefixation devices 110 such as wires, drills, bone taps and bone screwsthrough portions of the skeletal anatomy, such as the pelvis, that areoutside the margins of an osteotomy and further through the surgicalimplant 100. FIGS. 11A-11B illustrate the fixation device guide 1006including at least one adjustable fixation device holder 1101. FIG. 11Aillustrates a top view of an embodiment fixation device guide 1006including an opening 1100, the opening 1100 extending the entirethickness of the fixation device 1006 and comprising side walls 1103,and at least one fixation device holder 1101. The at least one fixationdevice holder 1101 comprising a housing 1104 with at least two openings1104 a, 1104 b at each end, the housing 1104 rotatably connected to theside walls 1103 of the fixation device opening 1100 by at least two pins1102. In an embodiment, the housing may be tubular.

FIG. 11B illustrates a 3-dimensional view of an embodiment fixationdevice guide 1006 with the at least one rotatable fixation deviceholders 1101. The at least one fixation device holder may comprise twoopenings 1104 a and 1104 b at each end configured to allow traversal ofthe fixation device 110 through the fixation device holder 1101 andtherefore through the fixation device guide 1006. The pins 1102 areconfigured to allow rotation of the at least one fixation device holder1104 around an axis “X”. The rotation of the at least one fixationdevice holder 1104 along axis “X” allows adjustment of the angle of afixation device 110 prior to insertion into osseous tissue, the angleadjustment is important to ensure the fixation device 110 would traversethe openings 107, 108 of the surgical implant 100 when it reaches thesurgical implant 100 disposed in opposed, spaced relation relative tothe fixation device guide 1006. In an embodiment, the pins 1102 may befixedly attached to the fixation device holder 1104, but rotatablyconnected to the side walls 1103. The connection between the pin and theside walls 1103 of the fixation device opening 1100 may include hardclicks or lock and release mechanisms to allow the fixation deviceholder 1104 to reach and remain at a rotational position.

In an embodiment, FIG. 11C illustrates a 3-dimentional view of a portionof an embodiment fixation device guide 1006. The fixation device guide1006 may include at least one channel 1100, the at least one channel1100 extending from the top surface 1006 a to the bottom surface 1006 bof the fixation device guide 1006 and including a top opening 1105 onthe top surface 1006 a and a bottom opening 1106 on the bottom surface1006 b of the fixation device guide 1006. The at least one channel 1100may be round, oblong, square or any shape configured to allow thefixation device 110 to traverse through the channel 1100 from the topopening 1105 to the bottom opening 1106. In embodiments, the fixationdevice guide 1006 may include multiple channels 1100 a, 1100 b, 1100 cdisposed in parallel orientation to each other. In an embodiment, asillustrated in FIGS. 11D-11E, the fixation device guide 1006 may includemultiple channels 1100 a, 1100 b, 1100 c disposed in non-parallelorientations relative to each other to allow fixation devices 110 a, 110b, 110 c, 110 d, different angles of entry into the osseous tissue.

In an embodiment, as illustrated in FIG. 11F, the fixation device guide1006 comprises at least one channel 1100 starting at the top opening1105 (rectangular in shape), the at least one channel 1100 extendingthrough the thickness (“D”) of the fixation device 1006 ending at thebottom opening 1106 (rectangular in shape). The top and bottomrectangular openings 1105, 1106 may include a length “L1” extendingsubstantially the entire length “L” of the fixation device guide 1006.For example, length “L1” of the opening 1101 may range from about 95% toabout 5% of the length “L”. The top and bottom rectangular openings1105, 1106 may include a width “W1” extending substantially the entirewidth “W” of the fixation device guide 1006. For example, width “W1” ofthe opening 1101 may range from about 95% to about 5% of the width

In embodiments, FIG. 12 illustrates positioning of the surgical implantsystem 1000 comprising the surgical implant 100, the surgical implantguide 1001, the attachment mechanism 1005, the fixation device guide1006, and at least one fixation device 110. The surgical implant 100 isinserted into a “V” shaped fracture 1203 created just above the anteriorinferior iliac spine (AIIS) 1201, the surgical implant 100 detachablyconnected to the surgical implant guide 1001 employing an attachmentmechanism 1005. The surgical implant 100 is further disposed in opposed,spaced relation relative to the fixation device guide 1006. Fixationdevice guide 1006 is disposed superior to the iliac crest 1202 and isconfigured to guide at least one fixation device 110 through the osseoustissue and further through an opening 107, 108 of the surgical implant100. In an embodiment, the fixation device guide 1006 may includemultiple multidirectional openings 1101 a on the top surface 1006 a anda rectangular opening 1101 b on the bottom surface 1006 b of thefixation device guide 1006. In an embodiment, a second fixation device110 through the osseous tissue passed the fracture 1203 withouttraversing through openings 107, 108 of the surgical implant 100 and atleast a second fixation device 110. The at least second fixation device110 may be inserted into a space “S” (FIG. 6B) distal to the surgicalimplant's distal member 103. Upon installation of a trapezoidal surgicalimplant 100, the space “S” is created distal to the distal member 103 ofthe surgical implant 100. The second fixation device 110 may be insertedin or traverse the space “S” to improve bone healing and stabilizationto the osseous tissue and the fracture 1203 by imparting compressingforces. The depth of the space “S” (i.e., distance between the distalmember 103 of the surgical device to the distal end of the fracture1203) depends on the length of the first and second side members 101,102 of the surgical device 100. In embodiments, the depth of the space“S” may range from about 4 mm to about 3 cm, particularly, from about 1cm to 2.5 cm.

In an embodiment, FIG. 13A illustrates a 3-dimensional view of anosteotome guide system 1300 comprising at least one osteotomy protector1301 and an osteotome guide 1400.

In an embodiment, FIG. 13B illustrates front and back views of anosteotomy protector 1301. The osteotomy protector 1301 comprising aproximal end 1301 a configured to connect to the osteotome guide 1400, adistal end 1301 b configured to be inserted into and adjacent anatomicalstructures inside a patient's body, an outside surface 1031 c, and aninside surface 1301 d. The inside surface 1301 d may be configured toinclude at at least one elongated ridge 1304 having a length “L1,” theat least one elongated ridge 1304 extending substantially the entirelength “L” of the osteotomy protector 1301. The osteotomy protector 1301may be positioned inside a subject's body at the location of plannedosteotomy procedure and configured to guide osteotomes which enter thesubject's body along their cutting route, along its at least oneelongated ridge 1304, and protect and shield anatomical structures, suchas arteries and nerves, located adjacent to or near the cutting route ofan osteotome from injury during the procedure. Illustrating a crosssection 1305 of the embodiment osteotomy protector 1301, the osteotomyprotector 1301 may include two ridges 1304 configured to capture andguide an osteotome which enters the patient's body. The osteotomyprotector 1301 may further include a connection mechanism 1302 at theproximal end 1301 a to attach and separate the osteotomy protector 1301from the osteotome guide 1400. The connection mechanism 1302 may includea hole/button, snap button/hole, screw/hole or other known mechanism forconnecting the osteotomy protector 1301 to the osteotome guide 1400.

The osteotomy protector 1301 is formed from biocompatible material(s)including, but not limited to metals and metal alloys, such as stainlesssteel, cobalt chrome, titanium, and titanium alloys, as well aspolymers, such as polyether ether ketone (“PEEK”), or combinations ofthe aforementioned materials. The osteotomy protector 1301 may be madeusing an additive manufacturing process, for example, by printing orfoaming material(s) having sufficient strength, and resiliency as neededor desired for a surgical procedure. For a detailed description ofadditive manufacturing processes suitable for forming the osteotomyprotector 1301, reference can be made to U.S. Pat. Appl. Pub. No.2016/0213485 to Schaufler et al., U.S. Pat. Appl. Pub. No. 2016/0213487to Wilson et al., U.S. Pat. Appl. Pub. No. 2016/0213488 to Moore et al.,and U.S. Pat. No. 9,987,051 to Nunley et al., the entire content of eachof which is hereby incorporated by reference herein.

In an embodiment, FIGS. 14A-14C illustrate the osteotome guide 1400configured to guide the trajectory, control distance of and stabilizeosteotomes (not shown) during an osteotomy procedure. When creating cutsor fractures on anatomical structures, such as the skeletal system, anosteotome guide 1400 may be used to avoid advancing osteotomes 1600 toodeep into the patient causing harm to neurovascular tissues. Forexample, in the pelvis, to perform an osteotomy through the ileumbetween the anterior inferior iliac spine (AIIS) and anterior superioriliac spine (ASIS), anteriorly, and the greater sciatic notch,posteriorly, several important anatomical structures must be protected,including the superior gluteal artery and other neurovascularstructures. If osteotome is advanced too far, it could sever or damageimportant neurovascular structures.

In embodiments, the osteotome guide 1400 may comprise a housing 1401, atleast one guiding channel 1402, at least one connection mechanism 1403and at least one securing mechanism 1404. The housing 1401 may includeat least a proximal surface 1401 a and a distal surface 1401 b andhouses the at least one guiding channel 1402. The at least one guidingchannel 1402 may include a first opening 1402 a on the proximal surface1401 a of the housing 1401 and a second opening 1402 b on the distalsurface 1401 b of the housing 1401. The depth “D1” of the at least oneguiding channel 1402 is the same as the depth “D” of the housing 1401,the guiding channel 1402 is configured to receive and guide osteotomesentering through the first opening 1402 a, traversing the channel 1402in the housing 1401 and exiting the second opening 1402 b to impaleosseous tissue. In embodiments, the housing 1401 may include more thanone separate guiding channels 1402 each extending the entire depth “D”of the housing 1401 parallel to the top or bottom surfaces 1041 c, 1041d of the housing 1041, positioned at equal distances to one another. Inother embodiments, multiple guiding channels 1402 may start at more thanone first openings 1402 a and converge inside the housing 1401 to exitthrough one second opening 1402 b. FIGS. 14A and 14B each illustrate3-dimentional views of embodiment housings 1401.

The osteotome guide 1400 may be positioned at a fracture site in amanner that the second opening 1402 b is positioned adjacent to thecutting location. In this orientation, the osteotome immediately cutsthe target bone as it exits the housing 1401 of the osteotome guide 1400at the second opening 1402 b. The osteotome guide 1400 may comprise aconnection mechanism 1403 to removably connect the osteotomy protector1301. The connection mechanism 1403 may be a hole/button, snapbutton/hole, screw/hole or other known mechanism to complement theconnection mechanism 1302 of the osteotome protector 1301 and to connectthe osteotomy protector 1301 to the osteotome guide housing 1401.

In an embodiment, the osteotome guide 1400 may be fixed at the cuttinglocation and stabilized for the osteotomy procedure by at least onesecuring mechanism 1404. For example, the securing mechanism 1404 maycomprise a body 1404 a and an opening 1404 b, the securing mechanism1404 configured to receive pins or screws fixing the osteotome guide1400 to a nearby or adjacent bone. The body 1404 a may be fixedlyattached at its base to the housing 1401 and configured to allow fixingor connecting the osteotome guide 1400 to an adjacent bone. In anembodiment, FIG. 15A illustrates fixing the osteotome guide 1400 to anearby bony structure using a pin or a bone screw placed through theopening 1404 b of the at least one securing mechanism 1404.

In an embodiment, FIG. 14C illustrates a 3-dimensional view of theosteotome guide 1400 comprising a housing 1401, the housing 1401including at least one guiding channel 1402 with a first opening 1402 aand a second opening 1402 b. The first opening 1402 a having a length“L1” and width “W1.” The second opening having a length “L2” and width“W2.” The lengths “L1,” “L2” and widths “W1,” “W2” of the first andsecond openings 1402 a, 1402 b are configured to accept and guideosteotomes. In an embodiment, the first opening 1402 a is disposed inopposed relation relative to the second opening 1402 b, the length “L1”of the first opening is longer than the length “L2” of the secondopening 1402 b, resulting in a slanted guiding channel 1402 configuredto diverge multiple osteotomes onto one point.

In an embodiment, FIGS. 15A and 15B illustrate a side view of anosteotome guide system 1300 comprising the osteotome guide 1400, atleast one fixation device 110 and a supporting structure assembly 1500.The supporting structure assembly 1500 comprises a rod 1501 and asupporting structure 1505, the rod 1501 having a first end 1501 afixedly or movably connected to the osteotome guide housing 1401 and asecond end 1501 b configured to removably attach to or be secured to anexternal object 1502, such as a table. For example, the securing of theosteotome guide 1400 to an external object 1502 may be achieved byinserting the second end 1501 b of the rod 1501 into an opening 1507located on the supporting structure 1505 and securing the rod 1501 tothe supporting structure 1505 by tightening a screw 1508, such as shownin FIG. 15B. In embodiments, the supporting structure 1505 may befixedly attached to the external object 1502. Fixedly attaching the rod1501 to an external object may also be achieved using clamps oradhesives.

The osteotome guide 1400 is stabilized and connected to an adjacent ornearby bony structure, such as the pelvis bone, by at least one fixationdevice 110 placed through the opening 1404 b of the stabilizingmechanism 1404. The supporting structure assembly 1500 providesadditional or alternative mechanism which may be used to stabilize theosteotome guide 1400 by connecting the osteotome guide 1400 to anexternal object 1502, such as a table or chair. As such, the stabilizingmechanism 1404 fixes and stabilizes the osteotome guide 1400 to ananatomical structure of the subject while the supporting structureassembly 1500 fixes and stabilizes the osteotome guide 1400 to anexternal object 1502.

In an embodiment, FIG. 15C illustrates a 3-dimensional view of anembodiment multiple osteotome guide systems 1300, the osteotome guidesystem 1300 comprises multiple osteotome guides 1400, at least oneconnecting device 1509 and multiple a supporting structure assembly1500. It is contemplated that at least two osteotomy systems 1300 may beused for bilateral fracturing of bony structures, such as the pelvicbone. When two or more osteotomy systems 1300 are used, the multipleosteotome guides 1400 may be first secured to an anatomical structure ofthe patient using the stabilizing mechanism 1404. Each osteotome guide1400 a, 1400 b may be fixedly attached to an external object 1502 suchas a table, using a supporting structure assembly 1500, the supportingstructure assembly 1500 including the rod 1501, the supporting structure1505 fixedly connected to the external structure 1502 and the screw 1508configured to tighten the free end of the rod 1501 in the opening 1507.In embodiments, each osteotome guide 1400 a, 1400 b may also beconnected to each other by a connecting rod 1509 to further stabilizethe osteotome guides 1400 a, 1400 b against the subject's anatomicalparts.

The osteotome guide system 1300 components may be formed frombiocompatible material(s) including, but not limited to metals and metalalloys, such as stainless steel, cobalt chrome, titanium, and titaniumalloys, as well as polymers, such as polyether ether ketone (“PEEK”), orcombinations of the aforementioned materials. The osteotome guide 1400may be made using an additive manufacturing process, for example, byprinting or foaming material(s) having sufficient strength, andresiliency as needed or desired for a surgical procedure. For a detaileddescription of additive manufacturing processes suitable for forming theosteotome guide 1400, reference can be made to U.S. Pat. Appl. Pub. No.2016/0213485 to Schaufler et al., U.S. Pat. Appl. Pub. No. 2016/0213487to Wilson et al., U.S. Pat. Appl. Pub. No. 2016/0213488 to Moore et al.,and U.S. Pat. No. 9,987,051 to Nunley et al., the entire content of eachof which is hereby incorporated by reference herein.

In an embodiment, FIGS. 16A-16B illustrate a side view of variousdesigns of cutting devices or osteotomes 1600. FIG. 16A illustratesosteotomes 1600 comprising a head 1601, and a body 1602. The head 1601is fixedly connected to the body 1602. The head 1601 may include a width“W1” that is longer than the width “W2” of the of the body 1602. Thebody 1602 comprises a top end 1602 a and a bottom end 1602 b. The topend 1602 a is fixedly connected to the head 1601. The bottom end 1602 bincludes a sharp edge 1603 configured to cut through osseous tissue. Inan embodiment, the osteotome 1600 e may include a jagged sharp edge1603. In yet another embodiment, the osteotome 1600 d may only include abody 1602. The dimensions of embodiment osteotomes 1600 may be variableand determined based on the cutting size and distance required anddifferent sizes and shapes are contemplated for the embodimentosteotomes 1600.

In embodiment, FIG. 16B illustrates a 3-dimensional view of an osteotome1600 engaged in an osteotome guide 1400. The head 1601 of the osteotome1600 may include a width “W1” that is larger than the width “W” of theopening 1402 a of the osteotome guide 1400. The body 1602 of theosteotome 1600 may include a width “W2” that is smaller than the width“W3” of the opening 1402 a of the osteotome guide 1400. The body 1602 isconfigured to travel through the at least one channel 1402 of theosteotome guide 1400. The length “L2” of the body 1602 is longer thanthe depth “D” of the osteotome guide 1400. The length “L1” of the body1602 is determined based on the distance the osteotome 1600 must cut ananatomical structure, such as the osseous tissue. Because the width “W1”of the head 1601 is longer than the width “W” of the osteotome guide1400, the bottom end 1601 b of the head 1601 will touch the proximalsurface 1401 a of the osteotome guide housing 1401, stopping the cuttingprocess once the desired cutting distance is achieved by the osteotome1400, thus, preventing damage to distant anatomical structures such asneurovascular tissue.

In an embodiment, a method of installing the surgical implant 100 mayinclude forming an opening or fracture in the osseous tissue, such as inthe pelvic bone, along an osteotomy line 1503; inserting a surgicalimplant 100 in the opening; and, inserting a fixation device 110 throughthe osseous tissue and the surgical implant 100, anchoring the surgicalimplant 100 to the osseous tissue.

FIG. 17 illustrates a side view of pelvis bone and osteotome guidesystem 1300 positioned to create an opening along an osteotomy line1503. In an embodiment, the forming of an opening in osseous tissue maycomprise obtaining a fluoroscopy view of the pelvis, making a skinincision at the osteotomy line 1503 position; inserting a guide wire inthe osseous tissue, positioning and anchoring an osteotome guide 1400adjacent to the osteotomy line 1503 in the osseous tissue; insertingosteotome(s) 1600 through the osteotome guide 1400 to form the openingor fracture the osseous tissue at the osteotomy line 1503. In anembodiment, a fluoroscopy view of the pelvis may include fluoroscopyview parallel to the wall of the ilium in line with posterior column ina manner that there is no parallax visible, and the inner and outercortices of the ilium are in line with the ischium. In an embodiment, aguide wire 1701 may be advanced from the anterior third of the iliumthrough the inner and outer tables of the ilium posterior to theacetabulum and into the ischium. The guide wire 1701 may be placed withor without employing navigational tools such as O-arm™ or a robotic arm.In an embodiment, a bone tap 1702 may be advanced over the guide wire tominimize the bending of the guide wire during the procedure. Theosteotome guide 1400 may be placed adjacent and over the bone tap 1702,the bone tap 1702 informs and provides the correct plane of osteotomy.

In an embodiment method, the osteotomy procedure comprises using acutting device, such as a surgical scalpel, forming an opening in ormaking an incision in the skin over the osteotomy line 1503 location.The making an incision in the skin may include a vertical or horizontalcut at the level of the osteotomy line 1503, such as at AIIS, dissectingdown through the subcutaneous tissue, fat, and fascia down to the bone;dissecting the tissue on either side of the iliac bone and inserting theosteotomy protectors 1301 between the soft tissue and the exposedosseous tissue, for example, around greater sciatic notch to protect thesuperior gluteal nerve, artery and vein. The osteotome guide 1400 may beanchored and secured to the patient's osseous tissue, such as by pinningthe osteotome guide 1400 using a securing mechanism 1404 (for example,with two pins or four pins caudal and cephalad to level of osteotomy),and/or to an external object by using a supporting structure assembly1500. Based on preoperative planning (e.g., CT's and X-rays), the atleast one osteotome 1600 of desired length and width may be used to cutthe osseous tissue. In an embodiment, the bone tap 1702 may be placed ina manner to intersect the osteotomy line 1503 at the posterior sectionof the osteotomy line 1503. In such scenarios when bone tap 1702intercepts the osteotomy line 1503, the osteotome 1600 may be advancedin the osseous tissue until the osteotome 1600 reaches and interceptsthe bone tap 1702 at a posterior location of the osteotomy line 1503.The bone tap 1702 may be retracted just passed the osteotomy line 1503.The intercept of the bone tap 1702 and the osteotome 1600 may create anangulation measurement to allows the user to see the angle of correctionthrough the osteotomy.

In an embodiment, the inserting a surgical implant 100 may furtherinclude inserting the surgical implant 100 removably attached to asurgical implant guide system 1000, the surgical implant guide system1000 configured to align the surgical implant openings 107, 108 with thepath of fixation devices 110 inserted through osseous tissue outside ofthe opening formed in the osseous tissue by the osteotome 1600. Aligningthe openings on the fixation device guide 1006 with the openings 107,108 of the surgical implant 100, anchoring the surgical implant to theosseous tissue comprises, inserting at least one fixation device 110through the fixation device guide 1006 opening 1101, through the osseoustissue adjacent to the fixation device guide 1006; advancing thefixation device 110 through osseous tissue to reach the opening 107 ofthe surgical implant 100; traversing the fixation device 110 through theopening 107 and advancing the fixation device 110 through the cavity 109of the surgical implant 100 to reach the opening 108 of the surgicaldevice 100; traversing through the opening 108 of the surgical implant100; and, advancing the fixation device 110 through the osseous tissueadjacent to the opening 108. In an embodiment, inserting a fixationdevice 110 using a fixation device guide 1006 may further includeinserting a guide wire through the opening 1100 of the fixation deviceguide 1006; advancing the guide wire through the osseous tissue to reachthe opening 107; traversing the guide wire through the openings 107,cavity 109 and opening 108 of the surgical implant 100; and, advancingthe guide wire through the osseous tissue adjacent to the opening 108.Subsequently, inserting a fixation device 110 over the guide wire toensure that the fixation device 110 will traverse the osseous tissue andopenings 107, 108 of the surgical implant 100.

In an embodiment, the method of installing the surgical implant 100using a surgical implant guide system 100 may further include detachingthe surgical implant 100 from the attachment mechanism 1005 of thesurgical implant guide system 1000 and attaching a bone plate 500 to thesurgical implant 100. In embodiments, trial plates may be utilized forinitial fitting and size confirmation. A plate holder may be utilized toseat the bone plate 500 flush against the pelvic bone. Fixation devices110 may be inserted to secure the bone plate to the osseous tissue.Holes may be drilled into the osseous tissue prior to inserting fixationdevices 110 to minimize bone damage during the procedure. In anembodiment, prior to inserting the surgical implant 100, the at leastone cavity 109 of the surgical implant 100 may be filled with bonegrowth material. A standard wound closure procedure may then be used tocomplete the procedure.

In embodiments, the surgical implant 100 may be inserted in the pelvicbone for correction of spinal deformity by employing a surgical implantguide system 1000. At least one fixation device 110 may be inserted fromthe iliac crest towards ischium, through the osseous tissue of ilium,traversing through the openings 107, 108 of the inserted surgicalimplant 100 and subsequently impaling through the osseous tissue locatedinferior to the surgical implant 100. Additional fixation devices 110may be inserted through the ilium and through the space “S” in thefracture 1203 but without engaging or traversing openings 107, 108 ofthe surgical implant 100, imparting compression forces on the bone topromote healing.

The various embodiment methods may be performed using navigationaland/or robotic systems. Navigational tool may allow a perpendicularosteotomy by registering a CT scan obtained prior to surgery to theposition of the pelvis at time of surgery. Navigation tools may alsoallow for placement of fixation devices 110. Robotic arm may allow formaking pre-planned CT cuts for osteotomy and fixation device 110placement. For a detailed description of suitable navigational orrobotic systems and methods reference can be made to U.S. Pat. No.9,283,048 to Kostrzewski et al., U.S. Pat. No. 5,408,409 to Glassman etal., U.S. Pat. Appl. No. 2017/0056116 to Kostrzewski et al., U.S. Pat.App. No. 2015/0100066 to Kostrzewski et al., and U.S. Pat. No. 9,592,096to Maillet et al the entire content of each of which is herebyincorporated by reference herein.

The surgical implant 100, surgical implant system or assembly 10, or thesurgical implant guiding system 1000 may be provided in a kit. In anembodiment, the kit may be an assembled package including at least onesurgical implant 100 and at least one fixation device 110. The kit mayfurther include at least one bone plate 500. In another embodiments, thekit may include a plurality of surgical implants 100 of various sizes(e.g., surgical implants having different lengths and/or widths), aplurality of fixation devices 110 of various lengths (e.g., 45 mm, 60mm, etc.) and types (e.g., low-profile head screws, rounded-head screws,pins, shims, wedges, blades, etc.), and/or a plurality of bone plates500 of various configurations to allow a user to pick and choose one ormore suitable components for a surgical procedure. In anotherembodiment, the kit may include stackable surgical implants 800. Inanother embodiment, the kit may include surgical implant guiding system1000 in addition to the at least one surgical implant 100, at least onebone plate 500 and at least one fixation device 110. In an embodiment,the kit may include osteotome guide system 1300, including osteotomeguide 1400, osteotomy projectors 1301 and osteotomes 1600 of varioussizes, in addition to the at least one surgical implant 100, at leastone bone plate 500 and at least one fixation device 110. The kit mayinclude a first container or compartment including the at least onesurgical implant 100, and, optionally, the surgical implant guidingsystem 1000. The kit may include a second container or compartmentincluding the at least one fixation device 110. The kit may furtherinclude a third container or compartment including the at least one boneplate 500. The kit may further include a fourth container including anosteotome guide system 1300. The kit may include a fifth containerincluding osteotomes 1600.

It is envisioned that the surgical implant 100 may be solid, open-faced,and/or expandable. The surgical implant 100 may be expanded by an activeor passive mechanism and/or include a height expansion/reductionmechanism to allow for dynamic changes to the height and/or length ofthe surgical implant 100. The surgical implant 100 can be built in-situby a user inside of osseous tissue to tailor the surgical implant 100 toconform to the anatomy of an individual patient.

While various embodiments of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims. Throughout this description, the term “proximal”refers to a portion of a system, a device, or a component thereof, thatis closer to a user, and the term “distal” refers to a portion of thesystem, the device, or the component thereof, that is farther from theuser. In the drawings and the foregoing description, terms such as“front,” “back,” “upper,” “lower,” “top,” “bottom ,” “side,” and similardirectional terms are used for convenience of description and are notintended to limit the disclosure.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description and include non-limitingexemplary embodiments. The foregoing is not intended to limit thedisclosure to the form or forms disclosed herein. In the foregoingDetailed Description for example, various features of the disclosure aregrouped together in one or more embodiments for the purpose ofstreamlining the disclosure. This method of disclosure is not to beinterpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A surgical implant assembly comprising: at leastone surgical implant comprising: a first side member, including at leastone first opening, a first side member distal end and a first sidemember proximal end, wherein the first side member has a contoured shapematching the contoured shape of adjacent bone to which it will beplaced; a second side member, including at least one second opening, asecond side member distal end and a second side member proximal end, thesecond side member disposed in opposed relation relative to the firstside member, wherein the first side member has a contoured shapematching the contoured shape of adjacent bone to which it will beplaced; a distal member including a right end and a left end,interconnecting the first side member and the second side member, theright end connecting to the first side member distal end and the leftend connecting to the second side member distal end; a top member and abottom member disposed in opposed, spaced relation relative to the topmember, the top and bottom members are interconnected through theirparameter by the first side member, the second side member, the distalmember, and a proximal member; and a fixation device insertable throughthe at least one first opening and the at least one second opening,wherein the fixation device is inserted through a first osseous tissue,into the at least one first opening, the at least one second opening anda second osseous tissue.
 16. A method of implanting a surgical implantinto an osseous tissue comprising: forming an opening in the osseoustissue of a pelvis; inserting a surgical implant into the opening of theosseous tissue, the surgical implant comprising: first side member,including at least one first opening, a first side member distal end anda first side member proximal end, wherein the first side member has acontoured shape matching the contoured shape of adjacent bone to whichit will be placed; a second side member, including at least one secondopening, a second side member distal end and a second side memberproximal end, the second side member disposed in opposed relationrelative to the first side member, wherein the first side member has acontoured shape matching the contoured shape of adjacent bone to whichit will be placed; and a distal member including a right end and a leftend, interconnecting the first side member and the second side member,the right end connecting to the first side member distal end and theleft end connecting to the second side member distal end; and, anchoringthe surgical implant to the osseous tissue by inserting at least onefixation device through a first osseous tissue, the at least one firstopening, and the at least one second opening and a second osseoustissue.